U.S. patent number 10,449,296 [Application Number 16/272,628] was granted by the patent office on 2019-10-22 for compact auto-injector.
This patent grant is currently assigned to PIROUETTE MEDICAL LLC. The grantee listed for this patent is Pirouette Medical LLC. Invention is credited to Conor Cullinane, Matthew Kane, Elijah Kapas.
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United States Patent |
10,449,296 |
Kapas , et al. |
October 22, 2019 |
Compact auto-injector
Abstract
A novel single use auto-injector for delivering a fixed amount
of medicament is described. The auto-injector may include a sealed
housing rotatably held in a cover. Once the auto-injector is
positioned at the injection location, the user can transition the
housing from a locked to an armed position. The user can then
compress the sealed housing into the cover, triggering activation
mechanisms that initiate the injection. A first activation
mechanism engages an interlock to prevent reuse of the
auto-injector. A second activation mechanism straightens and
extends a curved needle to a set the exposed needle length. A third
activation mechanism pierces a sealed reservoir allowing the
medicament to be forced through the injection needle. Following the
injection, the auto-injector expands and interlocks, retracting the
needle into the auto-injector and preventing reuse.
Inventors: |
Kapas; Elijah (Medford, MA),
Kane; Matthew (Somerville, MA), Cullinane; Conor
(Hampton, NH) |
Applicant: |
Name |
City |
State |
Country |
Type |
Pirouette Medical LLC |
Boston |
MA |
US |
|
|
Assignee: |
PIROUETTE MEDICAL LLC (Hampton,
NH)
|
Family
ID: |
63684474 |
Appl.
No.: |
16/272,628 |
Filed: |
February 11, 2019 |
Prior Publication Data
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Document
Identifier |
Publication Date |
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US 20190167905 A1 |
Jun 6, 2019 |
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Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
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16117911 |
Aug 30, 2018 |
10265471 |
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62568567 |
Oct 5, 2017 |
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62552052 |
Aug 30, 2017 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61M
5/20 (20130101); A61M 5/14244 (20130101); A61M
5/2033 (20130101); A61M 5/46 (20130101); A61M
5/14248 (20130101); A61M 5/31565 (20130101); A61M
2005/2073 (20130101); A61M 5/3232 (20130101); A61M
5/3202 (20130101); A61M 5/31571 (20130101); A61M
5/2466 (20130101); A61M 5/3158 (20130101); A61M
2005/206 (20130101); A61M 5/24 (20130101); A61M
2005/14284 (20130101) |
Current International
Class: |
A61M
5/20 (20060101); A61M 5/46 (20060101); A61M
5/142 (20060101); A61M 5/32 (20060101); A61M
5/315 (20060101); A61M 5/24 (20060101) |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
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WO-2007051563 |
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May 2007 |
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WO |
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WO-2009062510 |
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WO |
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WO-2011012849 |
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Feb 2011 |
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WO |
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WO-2012058192 |
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May 2012 |
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WO |
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WO-2013147440 |
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Oct 2013 |
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WO |
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WO-2014072993 |
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Jul 2014 |
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WO |
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WO-2015/117913 |
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Aug 2015 |
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WO |
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WO-2016055505 |
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Apr 2016 |
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WO |
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WO-2017/004315 |
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Jan 2017 |
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WO |
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WO-2017072333 |
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May 2017 |
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WO |
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WO-2017083622 |
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May 2017 |
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WO |
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WO-2017118681 |
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Jul 2017 |
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WO |
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Other References
http://www.enableinjections.com/_(Last Accessed Apr. 8, 2019).
cited by applicant .
http://www.enableinjections.com/ (2017). cited by applicant .
International Search Report and Written Opinion dated Nov. 15, 2018
for International Application No. PCT/US2018/048878, 15 pages.
cited by applicant .
https://exposingmodernmugwumps.com/2015/04/13/the-epibracelet-a-wearable-p-
ortable-and-fashionable-automatic-epinephrine-injection-device/_(Last
Accessed Apr. 5, 2019). cited by applicant.
|
Primary Examiner: Shah; Nilay J
Attorney, Agent or Firm: Goodwin Procter LLP
Parent Case Text
CROSS-REFERENCE TO RELATED APPLICATION
This application is a continuation of and claims the benefit of
priority to U.S. patent application Ser. No. 16/117,911 entitled
"Compact Auto-Injector," filed on Aug. 30, 2018, which claims the
benefit of priority to U.S. Provisional Patent Application No.
62/552,052 entitled "Compact Auto-Injector," filed on Aug. 30,
2017, and U.S. Provisional Patent Application No. 62/568,567
entitled "Protective Case for an Auto-Injector," filed on Oct. 5,
2017, the contents of all of which are incorporated herein by
reference in their entireties.
Claims
What is claimed is:
1. A compact, high aspect ratio auto-injector for delivering a
medicament dose subcutaneously or intramuscularly, the
auto-injector comprising: a housing; a medicament dispensing system
disposed within the housing and comprising a medicament reservoir
adapted to contain the dose; and a needle extension mechanism
coupled to the medicament reservoir, the needle extension mechanism
comprising a curved injection needle and a needle guide adapted to
straighten the curved injection needle during deployment of the
curved injection needle through the needle guide, such that the
curved injection needle is non-self-straightening and is
straightened by the needle guide, to facilitate dispensing of the
dose by the auto-injector.
2. The auto-injector according to claim 1, wherein the housing
comprises a sealed housing rotatably retained in a cover.
3. The auto-injector according to claim 2, where the housing
further comprises an interface to receive user input to facilitate
a manual rotation of the housing relative to the cover from a first
locked position to a second unlocked position.
4. The auto-injector according to claim 3, wherein at least one of
the housing, the cover, a label, and a component directly visible
to a user comprises indicia indicating the locked position, the
unlocked position, and an armed position.
5. The auto-injector according to claim 3, wherein the
auto-injector further comprises a biasing member, such that when
the housing is rotated to the unlocked position, the sealed housing
is automatically displaced axially relative to the cover,
increasing a height of the auto-injector.
6. The auto-injector according to claim 5, wherein the biasing
member comprises a spring that is at least one of integrally formed
with the housing integrally formed with the cover, and disposed
between the housing and the cover.
7. The auto-injector according to claim 5, wherein the
auto-injector further comprises an interlock, such that the housing
cannot be rotated relative to the cover or displaced axially
relative to the cover without removal of the interlock.
8. The auto-injector according to claim 5, wherein manual
compression of the auto-injector in an armed position, reduces the
height of the auto-injector, and activates a mechanism that
straightens and extends a distal end of the curved injection needle
through the housing, dispenses the dose through the curved
injection needle, and activates an interlock.
9. The auto-injector according to claim 8, wherein upon release of
the manual compression, the biasing member automatically displaces
the housing axially relatively to the cover, increasing the height
of the auto-injector and retracting the distal end of the curved
injection needle into the housing.
10. The auto-injector according to claim 9, wherein the
auto-injector further comprises an interlock to prevent subsequent
manual compression of the auto-injector, thereby rendering the
auto-injector single-use.
11. The auto-injector according to claim 10, wherein the interlock
comprises an abutting structure in the housing and the cover.
12. The auto-injector according to claim 1, wherein the medicament
dispensing system further comprises a plunger within the medicament
reservoir and forming a sealed cavity for retaining the dose.
13. The auto-injector according to claim 12, wherein the medicament
dispensing system further comprises a dispensing needle in fluidic
communication with the curved injection needle.
14. The auto-injector according to claim 13, further comprising a
flexible tube interconnecting the dispensing needle with the curved
injection needle.
15. The auto-injector according to claim 13, wherein the medicament
dispensing system further comprises a spring, a retainer, and a
locking mechanism such that when the locking mechanism is released,
the spring displaces the retainer and forces the dispensing needle
to pierce the plunger to provide fluidic communication with the
dose.
16. The auto-injector according to claim 15, wherein the cover
comprises a second trigger to release the retainer and the locking
mechanism.
17. The auto-injector according to claim 15, wherein the spring
further displaces the plunger to pump the dose out of the vial and
through the dispensing needle to the curved injection needle.
18. The auto-injector according to claim 15, wherein the spring
comprises a compression spring.
19. The auto-injector according to claim 1, wherein the needle
extension mechanism further comprises a needle barrel for
supporting the curved injection needle, a spring coupled to the
barrel for rotating the barrel to uncoil the curved injection
needle, and a barrel locking mechanism to prevent inadvertent
rotation of the barrel.
20. The auto-injector according to claim 19, wherein the spring
comprises a torsion spring.
21. The auto-injector according to claim 19, wherein a cover of the
housing forms an aperture aligned with the needle guide through
which a distal end of the curved injection needle passes during
rotation of the barrel.
22. The auto-injector according to claim 21, wherein release of the
barrel locking mechanism permits the spring to rotate the barrel
and deploy the curved injection needle.
23. The auto-injector according to claim 22, wherein the cover
comprises a first trigger to release the barrel locking
mechanism.
24. The auto-injector according to claim 19, wherein the needle
extension mechanism further comprises a needle barrel cap to secure
a proximal end of the curved injection needle to the needle
barrel.
25. A method of operating a compact, high aspect ratio
auto-injector for delivering a medicament dose subcutaneously or
intramuscularly, the autoinjector comprising a housing, a
medicament dispensing system disposed in the housing and comprising
a medicament reservoir adapted to contain the dose, and a needle
extension mechanism coupled to the medicament reservoir, the needle
extension mechanism comprising a curved injection needle and a
needle guide, the method comprising the steps of: triggering
deployment of a distal end of the curved injection needle through
an aperture in a cover of the housing aligned with the needle guide
to straighten the curved injection needle, wherein the curved
injection needle is non-self-straightening and is straightened by
the needle guide; triggering piercing of the medicament reservoir
to provide fluidic communication between the medicament reservoir
and the curved injection needle; dispensing the dose through the
curved injection needle at a desired injection location; and
thereafter, retracting the distal end of the curved injection
needle into the auto-injector.
26. The method according to claim 25, wherein the auto-injector
further comprises an interlock, such that the housing cannot be
rotated relative to the cover or displaced axially relative to the
cover without removal of the interlock.
27. The method according to claim 25, wherein the housing comprises
a sealed housing rotatably retained in the cover, the method
further comprising the steps of: manually rotating the housing
relative to the cover from a first locked position to a second
unlocked position, in which the sealed housing is automatically
displaced axially relative to the cover to an armed position,
increasing a height of the auto-injector.
28. The method according to claim 27, further comprising the step
of determining the locked position, the unlocked position, and the
armed position based on indicia on at least one of the housing, the
cover, a label, and a component directly visible to a user.
29. The method according to claim 27, further comprising the step
of adhering the cover to the desired injection location prior to
triggering of the auto-injector.
30. The method according to claim 25, wherein the step of
triggering piercing of the medicament reservoir comprises manually
compressing the auto-injector when the auto-injector is in the
armed position, which comprises activating the medicament
dispensing mechanism triggering piercing of a plunger within the
medicament reservoir with a distal end of a dispensing needle.
Description
TECHNICAL FIELD
The invention relates generally to medicament auto-injectors and,
more particularly, to an auto-injector of a relatively low profile
and high aspect ratio. The auto-injector allows for administration
of a desired dose of medicament intramuscularly or
subcutaneously.
BACKGROUND
The auto-injector market is growing rapidly through an increase in
prescriptions, along with new indications for use. Auto-injectors
are becoming more dominant as they provide an innovative approach
to administer drugs or biological products, and they may enhance
safety, improve dosing accuracy, and increase patient compliance,
particularly in self-administration settings.
Existing auto-injectors leave patients actively seeking an
alternative to address the anxiety they feel associated with
existing pain points; poor portability, unwanted attention,
accidental injections, and lacerations. An improved auto-injector
is needed.
SUMMARY OF THE INVENTION
Through a human-centered design focus, embodiments of the
auto-injector described herein are portable, intuitive, and
easy-to-use. The auto-injector technology is diversely applicable
to many indications for uses that require fixed dose, single-use
intramuscular or subcutaneous injections. Embodiments of the
auto-injector are designed to consider the human element. The
enhanced ergonomics of embodiments of the device, in combination
with the high aspect ratio injector technology, are designed to
match modern lifestyles. Embodiments of the invention include a
high aspect ratio auto-injector technology that enables the
creation of a portable as well as wearable auto-injector for safe
and effective dosing of epinephrine, and other medicaments (note
that the exemplary value ranges in the chart of FIG. 141 relate to
the delivery of multiple medicaments, but can be adjusted, as
necessary, to accommodate the delivery of other medicaments). FIG.
1 provides example illustrations of how the aspect ratio of an
auto-injector is calculated, using both conventional auto-injectors
and the inventive auto-injector described herein. As used herein,
and with reference to FIG. 1, height (H) is defined as the largest
straight-line length of the auto-injector away from the skin during
injection (perpendicular to the injection surface), and width (W)
is measured as the smallest straight-line length on the surface
that is in contact with a patient's skin during injection (parallel
to the injection surface).
The novel auto-injector technology can be readily incorporated into
an auto-injector that can be worn in a bracelet, pendant or other
accessory to ensure that the auto-injector is always within reach
in the event of an emergency. The objectives of a portable and
wearable auto-injector that is safe, easy to use, as well as other
objectives, will be apparent to those skilled in the art.
In one aspect, the invention is a compact auto-injector for
delivering a medicament dose subcutaneously or intramuscularly. The
auto-injector may be composed of two main components: a sealed
housing, and a cover. Disposed inside the sealed housing is a
medicament reservoir containing the medicament, a medicament
dispensing system (MDS) and a needle extension system (NES). Upon
time of injection, the medicament reservoir and needle extension
system are in fluidic connection.
The sealed housing may be rotatably retained in a cover. In one
embodiment, the sealed housing may be rotated relative to the cover
from an initial position, to a second position following a user
input through a designed interface. At least one of the components
comprising the sealed housing or the cover may include indicia
indicating the first, second, or subsequent positions. The sealed
housing may be bounded during the transition such that the sealed
housing may be displaced relative to the cover in a controlled
means. The auto-injector can further include a biasing member,
whose function includes displacing the sealed housing relative to
the cover. In various embodiments, the biasing member can be a
spring that is integrally formed with the sealed housing or cover
or conversely a separate component which can be disposed between
the sealed housing and the cover. The auto-injector may further
include an interlock, such that the sealed housing cannot be
displaced unless the mechanism has been removed or released by the
user when use of the auto-injector is required.
To assist the user in performing a proper administration, the
auto-injector should be correctly oriented at the time of
injection. The auto-injector may assist orientation with labeling,
tactile surfaces, material color or transparency, and other indicia
indicating select sides. Furthermore, the auto-injector may present
itself with rotational aids, whereas the aids can be contoured,
textured, coated or combination of such to further indicate
orientation and operation. In addition, the auto-injector can
include a viewing window into the internals of the auto-injector
for medicament inspection which may further assist the user in
establishing orientation.
In one aspect the sealed housing is composed of two components; a
top and bottom half that are mated together. Disposed inside the
sealed housing is a medicament reservoir containing the medicament,
a medicament dispensing system (MDS), and a needle extension system
(NES). The embodiment of the bottom half may provide an aperture
for the injection needle to pass through. The two halves, are of
such geometry that they may locate and secure the internal
components. The two halves which comprise the sealed housing may
provide a mechanism or interface for rotating the housing relative
to the cover. In some embodiments the sealed housing may aid in
determining the fixation location for the MDS, and the NES, as well
as aid in the releasing of both systems at time of injection.
Additionally, the housing may provide a feature for determining the
angular displacement or rotation of the needle barrel that the
injection needle is affixed to. The sealed housing may aid in
providing alignment during the displacement relative to the cover.
Furthermore, the two halves may each provide features to assist in
assembly of the two halves to ensure the correct internal
alignment. The sealed housing can provide a means of bracing or
supporting the injection needle. In addition, the two halves may
contain or align the interlocks for preventing displacement of the
sealed housing relative to the cover, once the injection has been
performed.
The medicament dispensing system (MDS) which dispenses the
medicament is composed of a plunger, a biasing member, a retainer,
and a keeper. The biasing member may be similar to a mechanical
compression spring. The spring may be held in a state preserving
potential energy to be released at the time of injection. The
retainer which displaces the plunger, may bound the spring on one
end and may have a fixation point on the opposite end. The retainer
may facilitate a self-fixation or be fixed in place with a separate
locking mechanism which may be released or unlocked at the time of
injection. The keeper may bound the side of the spring opposite of
the retainer and control the displacement of the retainer relative
to the keeper. The displacement of the retainer relative to the
keeper is proportional to the volume of medicament dispensed. The
MDS may further include a dispensing needle coupled to the retainer
in constant fluidic communication to the injection needle. Once the
retainer contacts the plunger, the dispensing needle pierces the
plunger and is in communication with the contained medicament, and
therefore, the medicament is in fluidic connection with the
injection needle as well. Once released, the retainer further
displaces the plunger to pump the dose out of the reservoir,
through the dispensing needle, through the fluidic connection, and
through the injection needle. A flexible or combination of a rigid
and flexible tube may be used to interconnect the dispensing needle
with the injection needle.
In certain embodiments the needle extension system (NES) can
include a curved injection needle, a needle barrel for supporting
the curved injection needle, a needle barrel guide for aligning the
needle barrel and injection needle during administration, and a
biasing member coupled to the needle barrel for rotating the needle
barrel to straighten the curved injection needle to deploy the
distal end of the tissue. The biasing member may be a torsion
spring. In some embodiments, the axis of rotation of the needle
barrel may be substantially perpendicular to a longitudinal axis of
the medicament reservoir. The NES can include a needle barrel cap,
or another means of fixating or securing a proximal end of the
injection needle to the barrel. Additionally, the needle barrel cap
may aid in securing the flexible tubing to the needle. The barrel
cap and or barrel may provide a means of determining the starting
and ending rotational position of the injection needle proportional
to the depth of injection. In certain embodiments the needle barrel
may be secured with a locking mechanism to maintain the potential
energy of the torsion spring while held under load, to be released
or removed at the time of injection. Furthermore, the needle barrel
guide may maintain the concentricity of the needle barrel during
the injection. The step of triggering the deployment of the curved
injection needle through the aperture in the housing can include
manually compressing the auto-injector when the housing is aligned
with the cover for an injection and the rotation of the needle
barrel to drive the distal end of the curved injection needle
through the aperture. Advantageously, the step of retracting the
distal end of the injection needle through the aperture, results
from releasing the manual compression of the auto-injector.
Following the injection, the displacement of the sealed housing
relative to the cover may actuate an interlock, preventing further
reuse of the auto-injector.
In certain embodiments the housing is protected by the cover which
provides protection for the sealed housing during the storage of
the auto-injector. The cover may also provide a means of bounding
the sealed housing, such that the sealed housing is displaced with
respect to the cover in a controlled manner. In various
embodiments, a biasing member facilitates this displacement of the
housing relative to the cover. The biasing member can be a spring
that is integrally formed with the cover, or sealed housing, or
conversely a separate component which can be disposed between the
sealed housing and the cover. The cover may act or perform as the
triggering mechanism for the injection. In addition to acting or
performing as a protection and a triggering mechanism, the cover
may also provide a stable base or platform to perform the
injection. The injection contact surface of the cover may provide a
tactile surface, which can facilitate the following
functionalities: provide a stabilizing base for the auto-injector
during injection, aid the user in establishing orientation, as well
as affix the auto-injector to the injection location through the
means of an adhesive layer or other attachment means. Furthermore,
the bounding of the sealed housing by the cover may serve as a
means of alignment during the injection. Once the sealed housing
has been displaced relative to the cover to perform an injection,
the cover will maintain alignment during the manual compression of
the auto-injector from the armed to injection position to release
the MDS and NES. The manual compression of the sealed housing while
performing an injection, reduces the total height of the
auto-injector and causes the sealed housing to contact with the
intended triggers or protrusions on the cover. The contact with the
triggers or protrusions between the cover and the sealed housing
while performing an injection, due to the compression of the
auto-injector by the user may release the energy stored in the
biasing members to both deploy the injection needle and dispense
the medicament. Upon compressing the sealed housing relative to the
cover, the distal end of the injection needle will protrude past
the cover, through an aperture, and dispense the desired dose. In
some embodiments the cover may serve as a means of straightening
the injection needle and provide a backing to support the injection
needle during injection. In this manner, the length of the
injection needle that is deployed into the tissue can be straight
and perpendicular to the injection surface. Additionally, the cover
can provide a means of guiding the sealed housing during the manual
compression to aid in the alignment between the two components, to
ensure proper release of the MDS and NES. Upon releasing the
applied compression force, the biasing member displaces the sealed
housing relative to the cover, increasing the height of the
auto-injector and retracting the distal end of the injection needle
to conceal the needle and protect the user from accidental needle
sticks. Advantageously, the auto-injector can include an interlock
to prevent a subsequent manual compression of the auto-injector,
thereby rendering the auto-injector single-use. The interlock can
be an abutting structure in the housing and the cover. The method
mentioned above includes the steps of triggering deployment of the
curved injection needle through an aperture in the housing,
straightening of the injection needle, to embed the distal end of
the injection needle in tissue at a desired depth, triggering
piercing of the medicament reservoir with the dispensing needle to
provide fluidic communication between the reservoir and the
injection needle, dispensing the dose through the injection needle
and, thereafter, retracting the distal end of the injection
needle.
In certain embodiments the auto-injector will be presented with a
safety mechanism to be removed firstly before any subsequent
operations. The injection surface may be exposed to the user once
the safety mechanism has been removed, further aiding in
establishing an auto-injector orientation. The safety mechanism may
also provide a means of preventing the sealed housing from
displacing relative to the cover prior to removal, such that the
injection sequence may not commence without first removing said
mechanism. Alternatively, or additionally, the safety mechanism may
protect the user from the injection needle if an accidental
discharge were to happen or remove a protective shroud or sheath
that would perform a similar functionality. Therefore, the removal
of the safety mechanism may provide or facilitate the following
functionalities: establish orientation of the auto-injector,
provide an interlock to prevent the displacement of the sealed
housing relative to the cover prior to removal, protecting the user
from the injection needle, removing a conjoined or coupled
component that would further protect the injection needle or user
from said injection needle, as well as protecting a tactile coating
or surface on the injection contact surface of the cover.
Prior to performing the injection, the injection needle in the NES
and the dispensing needle in the MDS may be covered or sealed to
maintain predetermined cleanliness criteria during storage of the
auto-injector. Subsequently one embodiment of the auto-injector may
provide the user with protection from the distal end of the
injection needle by the means of a needle sheath. The needle sheath
may fully encase the injection needle to prevent any contamination
to the needle prior to use. In one embodiment the needle sheath is
used in conjunction with another component to protect the distal
portion of the injector needle, which will be embedded in the
tissue, from contaminants. The needle sheath may also provide a
means to prevent the needle from injuring the user if an accidental
discharge were to occur. In other embodiments, the needle sheath
may be fixed to the safety mechanism to aid in preventing an
accidental injection. The needle sheath may provide a means of
fixation to aid in removal prior to use. In one embodiment the
needle sheath has a snap fit which allows the joining of the needle
sheath to the safety mechanism to assist in removal prior to
injection. Alternatively, the needle sheath may only serve to
prevent the injection needle from being contaminated and the safety
mechanism can provide the user with protection from an accidental
discharge of the injection needle.
In some embodiments the auto-injector may have an internal power
source to allow certain functionalities of the auto-injector during
storage, during injection, and post injection. The auto-injector
may provide audible instructions for performing an injection.
Additionally, connectivity of the auto-injector to everyday smart
devices allows for additional functionality. The connected smart
device may display visual and/or auditory instructions for
performing an injection. Certain embodiments may allow for the user
to monitor the temperature, and location of the auto-injector.
Additionally, the connected smart device may allow the user to see
if other auto-injectors are nearby. Additional embodiments may
allow the smart device to contact emergency responders or next of
kin once an injection has been initiated. Furthermore, information
about the auto-injector may be monitored remotely by the
manufacturer.
In one aspect, the invention relates to a compact, high aspect
ratio auto-injector for delivering a medicament dose subcutaneously
or intramuscularly. The auto-injector can include a housing; a
medicament dispensing system disposed within the housing and
including a medicament reservoir adapted to contain the dose; and a
needle extension mechanism coupled to the medicament reservoir, the
needle extension mechanism including a curved injection needle
adapted to be straightened during deployment of the needle to
facilitate dispensing of the dose by the auto-injector.
In some embodiments of the above aspect, the housing includes a
sealed housing rotatably retained in a cover. The housing can also
include an interface to receive user input to facilitate a manual
rotation of the housing relative to the cover from a first locked
position to a second unlocked position. In some cases, the housing,
the cover, a label, and/or a component directly visible to the user
includes indicia indicating the locked position, the unlocked
position, and an armed position. The auto-injector can also include
a biasing member, such that when the housing is rotated to the
unlocked position, the sealed housing is automatically displaced
axially relative to the cover, increasing a height of the
auto-injector. The biasing member can include a spring that
integrally formed with the housing integrally formed with the
cover, and disposed between the housing and the cover. In some
instances, the auto-injector also includes an interlock, such that
the housing cannot be rotated relative to the cover or displaced
axially relative to the cover without removal of the interlock. In
some cases, manual compression of the auto-injector in an armed
position, reduces the height of the auto-injector, and activates a
mechanism that straightens and extends a distal end of the
injection needle through the housing, dispenses the dose through
the injection needle, and activates an interlock. In such cases,
upon release of manual compression, the biasing member can
automatically displace the housing axially relatively to the cover,
increasing a height of the auto-injector and retracting the distal
end of the injection needle into the housing. The auto-injector can
also include an interlock to prevent subsequent manual compression
of the auto-injector, thereby rendering the auto-injector
single-use. The interlock can include an abutting structure in the
housing and the cover.
In some embodiments of the above aspect, the medicament dispensing
system can further include a plunger within the medicament
reservoir and forming a sealed cavity for retaining the dose. The
medicament dispensing system can include a dispensing needle in
fluidic communication with the injection needle. In some cases, the
auto-injector can include a flexible tube interconnecting the
dispensing needle with the injection needle. The medicament
dispensing system can also include a spring, a retainer, and a
locking mechanism such that when the locking mechanism is released,
the spring displaces the retainer and forces the dispensing needle
to pierce the plunger to provide fluidic communication with the
dose. In some cases, the cover includes a second trigger to release
the retainer and the locking mechanism. The spring (e.g., a
compression spring) may further displace the plunger out of the
vial and through the dispensing needle to the injection needle.
In some embodiments of the above aspect, the needle extension
mechanism can also include a needle barrel for supporting the
curved injection needle, a spring (e.g., a torsion spring) coupled
to the barrel for rotating the barrel to uncoil the curved
injection needle, and a barrel locking mechanism to prevent
inadvertent rotation of the barrel. The cover can form an aperture
through which a distal end of the injection needle passes during
rotation of the barrel to straighten the injection needle. In some
cases, release of the barrel locking mechanism permits the spring
to rotate the barrel and deploy the injection needle. In some
cases, the cover includes a first trigger to release the needle
barrel locking mechanism. The needle extension mechanism may also
include a barrel cap to secure a proximal end of the injection
needle to the needle barrel.
In another aspect, the invention relates to a method of operating a
compact, high aspect ratio auto-injector auto-injector for
delivering a medicament dose subcutaneously or intramuscularly. The
auto-injector can include a housing, a medicament dispensing system
including a medicament reservoir adapted to contain the dose, and a
needle extension mechanism coupled to the medicament reservoir, the
needle extension mechanism including a curved injection needle. The
method can include the steps of triggering deployment of a distal
end of a curved injection needle through an aperture in a cover of
the housing to straighten the injection needle; triggering piercing
of the medicament reservoir to provide fluidic communication
between the reservoir and the curved injection needle; dispensing
the dose through the injection needle at a desired injection
location; and thereafter, retracting the distal end of the
injection needle into the auto-injector.
In some embodiments of the above aspect, the auto-injector further
includes an interlock, such that the housing cannot be rotated
relative to the cover or displaced axially relative to the cover
without removal of the interlock. In some cases the housing can
include a sealed housing rotatably retained in the cover and the
method further includes manually rotating the housing relative to
the cover from a first locked position to a second unlocked
position, in which the sealed housing is automatically displaced
axially relative to the cover to an armed position, increasing a
height of the auto-injector. In some instances, the method further
includes the step of determining the locked position, the unlocked
position, and the armed position based on indicia on at least one
of the housing, the cover, a label, and a component directly
visible to the user. The method can further include adhering the
cover to the desired injection location prior to triggering of the
auto-injector. In some instances, the step of triggering piercing
of the medicament reservoir includes manually compressing the
auto-injector when the auto-injector is in the armed position,
which includes activating the medicament dispensing mechanism
triggering piercing of a plunger within the medicament reservoir
with a distal end of a dispensing needle. The step of triggering
piercing of the medicament reservoir can further include pumping
the dose out of the reservoir to the injection needle.
In some embodiments of the above aspect, the step of manually
compressing the auto-injector when the auto-injector is in the
armed position further includes activating the needle extension
mechanism triggering the deployment of the curved injection needle
through the aperture in the cover. In some cases, the step of
activating the needle extension mechanism including deploying the
curved injection needle through the aperture in the cover further
includes rotating a needle barrel to drive the distal end of the
curved injection needle through the aperture. In some cases, the
step of activating the needle extension mechanism includes
deploying a distal end of the curved injection needle through the
aperture in the cover to straighten the injection needle. The step
of retracting the distal end of the injection needle into the
auto-injector can result from releasing manual compression of the
auto-injector. The method can also include the step of removing the
auto-injector from the desired injection location after dispensing
the dose. The method can also include the step of automatically
interlocking the auto-injector after retraction of the needle to
prevent reuse of the auto-injector and exposure of a distal end of
the injection needle. The method can also include the step of
disposing of the auto-injector after a single use.
BRIEF DESCRIPTION OF THE DRAWINGS
In the drawings, reference characters generally refer to the same
parts throughout the different views. Also, the drawings are not
necessarily to scale, emphasis is instead generally being placed
upon illustrating the principles of the invention. In the following
description, various embodiments of the present invention are
described with reference to the following drawings, in which:
FIG. 1 is a comparison of existing auto-injector form factor aspect
ratios versus an example high aspect ratio auto-injector, according
to various embodiments;
FIG. 2 is a depiction of the injection sequence indicating a user's
inputted actions with the auto-injector and the subsequent
auto-injector outputs, according to various embodiments;
FIG. 3 is a schematic isometric view of an auto-injector in the
stored or locked position, according to various embodiments;
FIG. 4 is a schematic side view of the auto-injector in the stored
or locked position, according to various embodiments;
FIG. 5 is a schematic isometric exploded view of internals of the
auto-injector, according to various embodiments;
FIG. 6 is a schematic side exploded view of internals of the
auto-injector, according to various embodiments;
FIGS. 7-11 are schematic side view of the sequential steps in
performing an injection, according to various embodiments (e.g.,
depicted in FIG. 2);
FIGS. 12-140 are schematic views of various system assemblies and
components of auto-injectors, according to various embodiments;
and
FIG. 141 is a chart listing exemplary value ranges for certain
parameters of the auto-injector, according to various
embodiments.
DETAILED DESCRIPTION
A first embodiment of an auto-injector 1 is described below.
Example user interactions and inputs with the auto-injector 1 are
described first, followed by example internal mechanisms and
interactions of the auto-injector's 1 components.
To assist the user in performing a proper administration, the
auto-injector 1 should be correctly oriented at the time of
injection. The auto-injector 1 may assist orientation with
labeling, tactile surfaces, material color or transparency, and/or
other indicia indicating select sides. Furthermore, the
auto-injector 1 may present itself with rotational aids MC-301
(see, e.g., FIG. 29), which can be contoured, textured, coated (or
combinations thereof) such to further indicate orientation and
operation. In addition, the auto-injector 1 can include a viewing
window into the internals of the auto-injector 1 for medicament
inspection which may further assist the user in establishing proper
orientation.
In certain embodiments, the auto-injector 1 includes a safety
mechanism SS-200 (see, e.g., FIGS. 3-7) to be initially removed
before any subsequent operations. An injection surface MC-121 (see,
e.g., FIG. 17) may be exposed to the user once the safety mechanism
SS-200 has been removed, further aiding in establishing a proper
orientation. The safety mechanism SS-200 may also provide a means
of preventing the sealed housing MC-200, MC-300 (see, e.g., FIGS.
3-6) from displacing relative to the cover MC-100 (see, e.g., FIGS.
3-6) prior to removal, such that the injection sequence may not
commence without first removing said mechanism SS-200.
Alternatively, or additionally, the safety mechanism SS-200 may
protect the user from an injection needle NES-700 (see, e.g., FIG.
65) if an accidental discharge were to happen or remove a
protective shroud or sheath NES-100 (see, e.g., FIG. 38-40) that
performs a similar functionality. Therefore, the removal of the
safety mechanism SS-200 may provide or facilitate the following
functionalities: establish orientation of the auto-injector 1,
provide an interlock SS-204 (see, e.g., FIGS. 101-102) to prevent
the displacement of the sealed housing MC-200, MC-300 relative to
the cover MC-100 prior to removal, protecting the user from the
injection needle NES-700, removing a conjoined or coupled component
NES-100 that would further protect the injection needle NES-700 or
user from said injection needle NES-700, as well as protecting a
tactile coating or surface on the injection contact surface MC-121
(see, e.g., FIG. 17) of the cover MC-100.
In various embodiments, in addition to the internal components
discussed below, the auto-injector 1 includes two main parts, a
sealed housing MC-200, MC-300 rotatably retained in a cup-shaped
cover MC-100 that also forms the bottom side or injection contact
surface MC-121. The sealed housing MC-200, MC-300 is made from
upper MC-300 and lower MC-200 halves bonded together through the
means of ultrasonic welding or alternative means that provide
sufficient adhesion and strength. In some embodiments the bond
between the upper MC-300 and lower MC-200 halves may be such that
it is a hermetic seal. Furthermore, the housing MC-200, MC-300 or
one of the subsequent halves that compose the housing MC-200,
MC-300 may contain tabs MC-210 (see, e.g., FIG. 12), that are
molded or formed protrusions that guide and constrain the housing
MC-200, MC-300 during operation within the cover MC-100. The sealed
housing MC-200, MC-300 functions as the primary interface for the
user performing the subsequent injection. The two halves that form
the sealed housing, are of such geometry (e.g.: MC-201, MC-202,
MC-204, MC-205, MC-206, MC-207, MC-208, MC-211, MC-213, MC-214,
MC-216, MC-217, MC-218, MC-304, MC-305, MC-309, MC-310, MC-311,
MC-312, MC-313, MC-314, MC-316) that they may locate and secure the
internal components.
The cover MC-100, provides a protective shroud around the housing
MC-200, MC-300 and supports the housing for rotation. In some
embodiments, the first step in performing or initiating an
injection is to remove the safety mechanism SS-200. The next step
can be to place the injection contact surface MC-121 of the cover
MC-100 on location. As mentioned previously, the safety mechanism
SS-200 may aid the user in establishing an overall orientation of
the auto-injector 1; therefore, once the injection contact surface
MC-121 of the cover MC-100 is exposed from its removal it may
further establish this orientation. The injection contact surface
MC-121 of the cover MC-100 may provide a tactile surface which can
facilitate the following functionalities: provide a stabilizing
base for the auto-injector 1 during injection, aid the user in
establishing orientation, and/or affix the auto-injector 1 to the
injection location through the means of an adhesive or other
attachment means.
In various embodiments, the cover MC-100 has a spring SS-300 (see,
e.g., FIGS. 5-6) disposed or formed therein, to bias the housing
MC-200, MC-300 away from the cover MC-100 during activation, to
facilitate use. A sidewall of the cover MC-100 may include
channels, slots, detents, etc. MC-103 (see, e.g., FIG. 15) that
correspond to different positions MC-117, MC-118, MC-119, MC-120
(see FIG. 18) or positions (e.g., locked, unlocked, armed, and
injection) that cooperate with tabs or protrusions MC-210 (see
FIGS. 21-22) on a sidewall of the housing MC-200, MC-300 or such
components that form the housing MC-200, MC-300, to maintain
alignment and control relative movement between various positions
(e.g., locked, unlocked, armed, and injection). The channels,
slots, detents, etc. MC-103 formed in the cover MC-100 guide the
housing MC-200, MC-300 during the twisting, expanding, compressing,
and subsequent expanding of the auto-injector 1 to facilitate the
different phases of the injection method and use. In addition, the
cover MC-100 facilitates the means of activating an interlock
SS-100 (see, e.g., FIGS. 11-14) such that once the cover MC100 is
in an injection position MC-120 and injection has commenced,
subsequent expansion of the housing MC-200, MC-300 relative to the
cover MC-100 has occurred, the auto-injector 1 may not be
compressed a second time rendering the auto-injector 1 single use.
The triggering mechanism MC-109 (see, e.g., FIGS. 19-20) is
designed such that the interlock SS-100 will always be activated
before the MDS or the NES to ensure that the sharps injury
prevention feature functions, if the injection needle NES-700 is
ever deployed. The cover MC-100 may also contain geometry MC-101,
MC-102 or indicia, formed, molded or stamped to provide an
orientation of the housing MC-200, MC-300 for either assembly of
the auto-injector 1 or for operational administration.
In various embodiments, when the auto-injector 1 is in a stored
position MC-117 and prior to use, the auto-injector 1 is in a
locked position, in which the spring SS-300 is compressed and the
auto-injector 1 is constrained. To move from the locked position
MC-117 to the unlocked position MC-118, the user manually rotates
the housing MC-200, MC-300 by applying an activation force to the
grip surfaces MC-301 (e.g., one or more depressions, protrusions,
textures, coatings, or combinations, etc.) formed on the upper
surface MC-300 of the housing MC-200, MC-300. The user applied
force displaces the sealed housing MC-200, MC-300 relative to the
cover MC-100 from the locked position MC-117 to the unlocked
position MC-118. Indicia, such as alignment marks on the sidewalls
of the housing MC-200, MC-300 and the cover MC-100 may indicate the
different positions (MC-117, MC-118, MC-119, MC-120) of the
auto-injector 1. The alignment indicia may also be indicated using
labels or other auto-injector 1 components (e.g., interlock SS-100)
that are observable from the exterior surfaces. Once the housing
MC-200, MC-300 is rotated from the locked position MC-117 to the
unlocked position MC-118, the housing MC-200, MC-300 is biased away
from the cover MC-100, and the auto-injector 1 expands to the armed
position MC-119. The expansion from the unlocked position MC-118 to
the armed position MC-119 is performed automatically by means of
the stored potential energy in the biasing member SS-300, such that
the user only needs to apply an activating force to the grip
surfaces MC-301 to move the auto-injector 1 from the locked
position MC-117 to the unlocked position MC-118. The automatic
translation and rotation of the sealed housing MC-200, MC-300
relative to the cover MC-100 may be constrained and guided by the
tabs or protrusions MC-210 on the sealed housing MC-200, MC-300 and
channels, slots, detents, etc. MC-103 on the cover MC-100.
In various embodiments, once the housing MC-200, MC-300 is in the
armed position MC-119, the tabs or protrusions MC-210 on the
housing MC-200, MC-300, and the guides on the cover wall MC-103
prevent the housing MC-200, MC-300 from being rotated back to the
unlocked position MC-118 and the locked position MC-117. In the
armed position MC-119, the auto-injector 1 can only be vertically
displaced towards the injection position MC-120. The orientation of
the auto-injector 1 is such that the top side MC-300 is facing
upwards (i.e., away from the injection location), with the flat
bottom surface MC-121 of the cover MC-100 against the injection
site. To inject the medicament, the user applies a normal force,
perpendicular to the top side MC-300 pushing the sealed housing
MC-200, MC-300 into the cover MC-100 to commence the activation
sequence of the auto-injector 1 and injection of the medicament.
The interlock mechanism SS-100 is activated just before the
auto-injector 1 reaches the injection position MC-120, such that,
once the user releases pressure, the interlock SS-100 is engaged,
and a second injection cannot be attempted. To ensure complete
dosing, the user maintains force on the sealed housing MC-200,
MC-300 to maintain the injection position MC-120 for an allotted
duration, and then releases pressure on the top side MC-300 of the
auto-injector 1. The release of pressure on the sealed housing
MC-200, MC-300 may permit the sealed housing MC-200, MC-300 to
translate relative to the cover MC-100, by means of the biasing
member SS-300, thereby retracting the needle NES-700. In various
embodiments, since the interlocks SS-100 were previously activated
MC-109, they will engage themselves while the sealed housing
MC-200, MC-300 is translating relative to the cover MC-100. After
the injection has been performed and the interlock SS-100 has
engaged the triggering mechanism MC-109, a force of, at minimum,
twice the injection force on the sealed housing MC-200, MC-300 will
not permit exposure of the needle NES-700 from the injection
contact surface MC-121 of the cover MC-100 and is able to be safely
disposed of.
The following list of items (1-11) describes an example activation
sequence of internal components and mechanisms of the auto-injector
1 and the individual component interactions, according to various
embodiments.
1.) Before initiating an injection, the user can remove a safety
mechanism SS-200 before any subsequent operations. The safety
mechanism SS-200 protects the injection surface MC-121 such that
upon removal, the injection surface MC-121 is exposed to the user,
which may further aid in establishing proper orientation. The
safety mechanism SS-200 can also provide a means (e.g., interlock
SS-204) of preventing the sealed housing MC-200, MC-300 from
displacing relative to the cover MC-100 prior to removal, such that
the injection sequence may not commence without first removing said
mechanism SS-200. The safety mechanism SS-200 may also remove a
needle sheath NES-100 that protects the user from the injection
needle NES-700 in the event of an accidental discharge.
Additionally, the sheath NES-100 in combination with a barrier
NES-600 (see, e.g., FIGS. 38-40) can cover the injection needle
NES-700 and may prevent any possible contamination during storage
of the injection needle NES-700. Therefore, at the time of
injection, prior to the removal of the needle sheath NES-100, the
injection needle NES-700 is sterile.
2.) Following the removal of the safety mechanism SS-200, the user
can rotate the sealed housing MC-200, MC-300 from the locked
position MC-117 to the unlocked position MC-118, whereupon the
sealed housing MC-200, MC-300 is automatically moved to the armed
position MC-119 by a biasing member SS-300. As a result, the
housing MC-200, MC-300 translates and rotates a certain constrained
distance and angle. When the user applies a force and transitions
the sealed housing MC-200, MC-300 from the armed position MC-119 to
the injection position MC-120, the mechanisms that initiate the
internal activation sequences inside the sealed housing MC-200,
MC-300 are triggers or protrusions MC-106, MC-107 (see, e.g., FIGS.
15-16). The activation triggers or protrusions MC-106, MC-107 can
be molded or formed on a surface of the cover MC-100. Cavities
MC-202 (see, e.g., FIGS. 22-23) are molded or formed into the lower
half MC-200 of the sealed housing MC-200, MC-300 to allow the
sealed housing MC-200, MC-300 and the cover MC-100 to rotate and
translate relative to one another without interfering with or
damaging the activation mechanism MC-106, MC-107 or alignment
mechanism MC-105 (see, e.g., FIGS. 19-20). During the assembly,
activation, and injection, the protrusions or tabs MC-210, molded
or formed on the sealed housing MC-200, MC-300 and corresponding
channels, slots, detents, etc. MC-103 on the cover MC-100, may
interface to provide sufficient clearance and alignment to prevent
damage of the protrusions or triggers on the cover MC-105, MC-106,
MC-107. The cover MC-100 may also have alignment posts or
protrusions MC-105, that interface with corresponding cavities
MC-211 (see, e.g., FIG. 23) in the sealed housing MC-200, MC-300 at
the time of injection (e.g., when the auto-injector 1 is in
position MC-120) such that they may aid in the alignment of the
sealed housing MC-200, MC-300 and cover MC-100 to orient the
triggers MC-106, MC-107 on the cover MC-100 with the corresponding
locking mechanisms NES-500 (see, e.g., FIGS. 38-41), MDS-100 (see,
e.g., FIGS. 69-73) disposed in the sealed housing MC-200, MC-300.
In some embodiments, the cover MC-100 and/or sealed housing MC-200,
MC-300 may contain additional features (e.g., MC-103, MC-104,
MC-109, MC-115, MC-210, SS-102) that aid in maintaining alignment
between the sealed housing MC-200, MC-300 and the cover MC-100
during relative movement.
3.) When the user applies a force to the top surface MC-300 of the
sealed housing MC-200, MC-300 to compresses the sealed housing
MC-200, MC-300 into the cover MC-100 to perform the injection, the
first system to be activated may be the interlock system SS-100.
Activating the interlock system SS-100 first, ensures that when the
user deploys the needle extension system (NES), the interlock
system SS-100 will always engage the triggering mechanism MC-109.
In some embodiments, the interlocks SS-100 are activated by an
interference fit between the cover MC-109 and interlock SS-101
(see, e.g., FIGS. 98-100) when the sealed housing MC-200, MC-300 is
compressed during injection. Following the injection, and the
release of pressure on the sealed housing MC-200, MC-300, the
sealed housing MC-200, MC-300 may be automatically displaced
relative to the cover MC-100, and the interlocks SS-100 are
deployed or engaged. Prior to activation, the interlocks SS-100 can
be held in a stored state in cavities MC-201 (see, e.g., FIG. 103),
MC-314 (see, e.g., 29-34) in the sealed housing MC-200, MC-300.
4.) Following the activation of the interlocks SS-100, the needle
extension system (NES) can be activated. The corresponding needle
extension trigger or protrusion MC-107 on the cover MC-100 breaks
the plane of the sealed housing MC-200, MC-300 in a predetermined
location MC-203 (see, e.g., FIG. 23) and contacts the fixture or
locking mechanism NES-500 of the NES. The fixture or locking
mechanism NES-500 of the NES can preserve the potential energy of a
biasing member NES-800 (see, e.g., FIGS. 67-68). The biasing member
NES-800 may be coupled to the needle barrel NES-200 (see, e.g.,
FIGS. 46-50) at a specified contact point NES-202 (see, e.g.,
48-50). In one embodiment the biasing member NES-800 is a torsion
spring which rotates the needle barrel NES-200. The fixture or
locking mechanism NES-500 may maintain the potential energy of the
torsion spring NES-800 by an interference portion NES-201 (see,
e.g., FIG. 47) with the needle barrel NES-200. The contact portion
NES-501 (see, e.g., FIGS. 60-62) between the needle extension
trigger or protrusion MC-107 on the cover MC-100 and the fixture or
locking mechanism NES-500 disengages the locking mechanism NES-500,
releasing the potential energy stored in the torsion spring
NES-800. The release of the torsion spring NES-800 rotates the
needle barrel NES-200 and deploys the curved injection needle
NES-700. The housing may have an internal geometric portion MC-307
(see, e.g., FIG. 31) to facilitate the disengagement of the locking
mechanism NES-500 at the time of injection.
5.) Once the locking mechanism NES-500 is disengaged from the
needle barrel NES-200, the torsion spring NES-800 may rotate the
needle barrel NES-200. The injection needle NES-700 may be fixed to
and retained in the needle barrel NES-200 by a needle barrel cap
NES-300 (see, e.g., FIGS. 51-54) that mates element NES-308 (see,
e.g., FIGS. 53-54) with a corresponding recess NES-207 formed in
the needle barrel NES-200. The needle barrel cap NES-300 may secure
the injection needle NES-700 to the needle barrel NES-200 through a
friction fit between elements NES-306 (see, e.g., FIGS. 53-54),
NES-206 (see, e.g., FIGS. 46-47). In addition, the barrel cap
NES-300 may secure a flexible tubing NES-900 (see FIG. 40) to the
injection needle NES-700 through a friction or compression fitting
formed by elements NES-304 (see FIG. 51), NES-305 (see FIG. 51),
NES-204 (see FIG. 49), NES-205 (see FIG. 49). Furthermore, the
needle barrel cap NES-300 provides a contact surface NES-301 (see
FIG. 52) for limiting the needle barrel's NES-200 rotation to a
specific angle. In various embodiments, the bottom half MC-200 of
the sealed housing MC-200, MC-300 provides an interface MC-218
(see, e.g., FIGS. 21-22) which contacts the needle barrel cap
NES-300 during rotation to limit the angular displacement of the
barrel NES-200 to the desired rotation angle, proportional to the
desired injection depth. The barrel cap NES-300 and the bottom half
MC-200 of the sealed housing MC-200, MC-300 work together to
prevent the injection needle NES-700 from over rotating and ensure
that the proper injection depth is achieved. The needle barrel
NES-200 maintains alignment along its rotational axis during
rotation through guides (e.g., NES-203 (see FIG. 46), NES-303 (see
FIG. 51), NES-208 (see FIG. 48)) formed in the sealed housing
MC-200, MC-300 halves (e.g., MC-207, MC-312, MC-316, MC-302,
MC-310, MC-309, MC-216) as well as a needle barrel guide NES-400
(see FIGS. 55-59). These guides may maintain axial alignment and
prevent the needle barrel NES-200 and injection needle NES-700 from
translating relative to the sealed housing MC-200, MC-300 during
injection. The needle barrel guide NES-400 may also provide a
channel NES-401 (see FIG. 55) to brace and guide the NES locking
mechanism NES-500 (see, e.g., FIGS. 60-62) during auto-injector 1
storage and injection. In some embodiments the needle barrel cap
NES-300 can be ultrasonically welded (see welds NES-210 (FIG. 49),
NES-307 (FIG. 51) or utilize another means of joining the two
components together. Additionally, the NES components of the system
can be integrated independent of the housing MC-200, MC-300, during
assembly.
6.) Upon rotation of the injection needle NES-700, the distal end
NES-701 (see FIGS. 65-66) of the curved injection needle passes
through an aperture MC-204 (see FIG. 23) formed in the lower half
MC-200 of the sealed housing MC-200, MC-300 and makes contact with
a needle guide MC-110 (see FIG. 19) on the cover MC-100, such that
a portion of the curved injection needle NES-700 is straightened
during uncoiling. The location where the injection needle NES-700
contacts the surface MC-112, MC-113 (see FIG. 19) on the needle
guide MC-110 may be such that the distal end NES-701 (e.g., a
lancet) is not in contact with the guide MC-110 to mitigate the
chance of scoring or scraping the needle guide MC-110, and to
mitigate the chance of producing debris. In addition to the needle
guide MC-110, the sealed housing MC-200, MC-300 may provide a brace
MC-309 (see FIGS. 31-34) to further limit possible radial (with
respect to the needle axis) deflections during injection.
7.) After the needle barrel locking mechanism NES-500 has been
disengaged by the first trigger MC-107, further compression of the
housing MC-200, MC-300 into the cover MC-100, allows the second
trigger MC-106 to initiate release of the medicament dispensing
system (MDS) and deliver the medicament. Similar to the NES, the
medicament dispensing trigger MC-106 makes contact MDS-101 with a
corresponding fixture or locking mechanism MDS-100 and releases
said locking mechanism MDS-100. The trigger MC-106 makes contact at
an interface portion MDS-101 (see FIG. 74) when the fixture or
locking mechanism MDS-100 is in a predetermined location MC-203.
The fixture or locking mechanism MDS-100 maintains the stored
potential energy of a biasing member MDS-700 (see FIG. 72). In one
embodiment, the biasing member MDS-700 is a compression spring that
is bounded by a retainer MDS-400, MDS-300 (see FIGS. 72-73) and a
keeper MDS-200 (see FIGS. 72-73). The release of the fixture or
locking mechanism MDS-100 allows the retainer MDS-300, MDS-400 to
displace relative to the keeper MDS-200 to make contact with a
plunger MDS-900 (see FIG. 72). After contacting the plunger
MDS-900, the retainer MDS-300, MDS-400 and plunger MDS-900 displace
together. The total displacement of the retainer MDS-300, MDS-400,
and concomitantly the plunger MDS-900, is determined by the keeper
MDS-200 which may provide an interference or another feature
MDS-201 (see FIGS. 78-80), MDS-309 (see FIGS. 81-84), MDS-409 (see
FIGS. 85-88) to restrict the retainer's MDS-300, MDS-400 movement.
As such, the displacement of the retainer MDS-300, MDS-400 relative
to the keeper MDS-200 can be proportional to the amount of
medicament expelled from the reservoir MDS-800 (see FIGS. 94-95).
Furthermore, the housing MC-200, MC-300 may have sufficient
internal geometry MC-306 (see FIG. 31) to assist in the
disengagement of the fixture or locking mechanism MDS-100 during
injection.
8.) Upon release of the MDS fixture or locking mechanism MDS-100
(see FIG. 74), the retainer MDS-300, MDS-400 can be displaced due
to the stored potential energy of the compression spring MDS-700
and contact plunger MDS-900. A dispensing needle MDS-600 can be
coupled to the retainer MDS-300, MDS-400 and in fluidic contact
with the injection needle NES-700 through a flexible tubing
NES-900. Furthermore, the dispensing needle MDS-600 like the
injection needle NES-700 is protected with a protective barrier
MDS-500 to prevent any contamination prior to injection MC-120.
Therefore, the release of the compression spring MDS-700 causes the
retainer MDS-300, MDS-400 to contact the plunger MDS-900, forcing
the dispensing needle MDS-600 to pierce both the protective barrier
MDS-500 and the plunger MDS-900. The medicament is dispensed from
the reservoir MDS-800 out of the dispensing needle MDS-600 (see
FIG. 91) in the opposite direction of the movement of the plunger
MDS-900. In various embodiments, the retainer MDS-300, MDS-400 is
composed of two halves (e.g., MDS-300, MDS-400) that are
ultrasonically welded (e.g., with welds MDS-405, MDS-305 (see FIGS.
84,85)) together or by an alternative means that provides
sufficient adhesion and strength. The retainer halves MDS-300,
MDS-400 may secure the dispensing needle MDS-600 through a friction
fit (MDS-602, MDS-302, MDS-402 (see FIGS. 82, 84, 91)). In
addition, the retainer halves MDS-300, MDS-400 may secure the
flexible tubing NES-900 to the dispensing needle MDS-600 through a
friction or compression fitting MDS-303, MDS-304, MDS-403, MDS-404
(see FIGS. 83-85) to prevent any possible disengagement during
dispensing. When fitted together, each half of the retainer
MDS-300, MDS-400 may have orienting features MDS-301, MDS-401 (see
FIGS. 83-85) that force the proper alignment of the two halves
MDS-300, MDS-400 during assembly, which also act to maintain the
dispensing needle MDS-600 and tubing NES-900 in proper alignment.
To maintain a sealed reservoir MDS-800 and to not contaminate the
medicament, the dispensing needle MDS-600 may only penetrate the
protective barrier MDS-500 (see FIGS. 89-90) and plunger MDS-900 at
the time of injection.
9.) Both the needle extension and drug dispensing triggers MC-106,
MC-107, which activate the NES and MDS respectively, may have
complimentary contoured surfaces to their respective locking
mechanisms NES-501 (see FIGS. 60-62), MDS-101 (see FIG. 74) at the
point of contact to reduce the force required to disengage and
limit the induced stresses in the triggers MC-106, MC-107.
Additionally, via the predetermined interaction location MC-203,
the housings MC-200, MC-300 may provide bracing MC-219 (see FIG.
26) to limit any possible deflections in the triggers MC-106,
MC-107, induced by the disengagement forces.
10.) The proximal end MDS-604 (see FIG. 91) of the dispensing
needle MDS-600 may be fluidically connected to a proximal end
NES-703 (see FIG. 65) of the injection needle NES-700 by a length
of flexible hose or tubing NES-900. The timing of the activation of
the NES and MDS can be such that the injection needle NES-700 is
embedded into tissue and the drug is dispensed within a designated,
or predetermined time frame.
11.) After the injection, and the release of pressure on the sealed
housing MC-200, MC-300 by the user, the sealed housing MC-200,
MC-300 may automatically translate relative to the cover MC-100 due
to the biasing member SS-300. In some embodiments, the biasing
member is a compression spring SS-300. During the subsequent
expansion of the sealed housing MC-200, MC-300 the interlocks
SS-100 are removed from their cavities MC-201, MC-314 and restrict
any relative motion between the sealed housing MC-200, MC-300 and
cover MC-100. The interlocks SS-100 prevent the auto-injector 1
from being collapsed, thereby preventing subsequent extension of
the distal end NES-701 of the injection needle NES-700 from the
cover MC-100. The expansion of the sealed housing MC-200, MC-300
relative to cover MC-100 can be sufficient to fully withdraw and
conceal the injection needle NES-700 in the auto-injector 1.
Additionally, the channels, slots, detents, etc. MC-103 in the
cover MC-100 and the molded or formed tabs or protrusions MC-210 on
the sealed housing MC-200, MC-300 may prevent any rotation of
either the cover MC-100 or the sealed housing MC-200, MC-300
relative to one another. The interlocks SS-100 which prevent
subsequent collapse of the auto-injector 1 and the inability to
rotate the cover MC-100 or housing MC-200, MC-300 allow for a safe
means of disposal, preventing accidental needle exposure
NES-700.
The following paragraphs describe another embodiment of the
auto-injector 1, including alternate or complimentary
configurations and activation sequences of the auto-injector 1.
In this embodiment, the auto-injector 1 may have an internal power
source to allow certain functionalities of the auto-injector 1
during storage, during injection, and post injection. The
auto-injector 1 may provide audible instructions for performing an
injection. Additionally, connectivity of the auto-injector 1 to
everyday smart devices allows for additional functionality. The
connected smart device may display visual and/or auditory
instructions for performing an injection. Certain embodiments may
allow for the user to monitor the temperature, and location of the
auto-injector 1. Additionally, the connected device may allow the
user to see if other auto-injectors 1 are nearby. Additional
embodiments may allow the smart device to contact emergency
responders or next of kin once an injection has been initiated.
Furthermore, information about the auto-injector 1 may be monitored
remotely by the manufacturer.
Similar to the embodiment described above, this embodiments can
establish an orientation of the auto-injector 1 prior to performing
any injection, through proper human factor engineering principles.
The auto-injector 1 may present the user with an intuitive
interface, leveraging existing mental models from everyday
applications. In regard to the user interface, additional or
alternative embodiments will provide the same benefits with
possible variations of the following aspects: geometry or element
1101 (see FIG. 115), tactile surfaces, indicia, labeling, and/or
coloring, that may aid the user in establishing an orientation
prior to performing an injection.
In certain embodiments, the auto-injector 1 includes a safety
mechanism SS-200 to be removed before any subsequent operations.
The injection surface MC-121 may be exposed to the user once the
safety mechanism SS-200 has been removed, further aiding in
establishing the proper orientation. The safety mechanism SS-200
may also provide a means of preventing the auto-injector 1 from
moving from a locked position 3102 (see FIGS. 110-111) to an
unlocked position 3103, 3104 (see FIGS. 110-111) prior to removal,
such that the injection sequence may not commence without first
removing the safety mechanism SS-200. Alternatively, or
additionally, the safety mechanism SS-200 may protect the user from
an injection needle 4102 (see FIG. 122) if an accidental discharge
were to happen, or remove a protective shroud or sheath NES-100
that can facilitate similar functionality. Therefore, the removal
of the safety mechanism SS-200 may provide or facilitate the
following functionalities, for example: establish orientation of
the auto-injector 1, provide an interlock SS-204 to prevent
rotation of the sealed housing prior to removal, protect the user
from the injection needle 4102, remove a conjoined or coupled
component NES-100 that further protects the injection needle 4102
or a user from the injection needle 4102, and protect a tactile
coating or surface on the injection contact surface MC-121 of a
cover 3100 (see FIGS. 110-111).
In addition to the internal components discussed below, the
auto-injector 1 can include two main parts, a sealed housing 1100,
2100 (see FIGS. 105-107) rotatably retained in the cup-shaped cover
3100 that may also form the bottom side or injection contact
surface MC-121. The sealed housing can be made from upper half 1100
and lower half 2100 bonded together through the means of ultrasonic
welding or alternative means that provide sufficient adhesion and
joint strength. In some embodiments the bond between the upper half
1100 and the lower half 2100 may form a hermetic seal. In some
cases, the housing 1100, 2100 or one of the subsequent halves 1100,
2100 that compose the housing 1100, 2100 contain molded or formed
protrusions 2107 (see FIGS. 112-113) that guide and constrain the
housing 1100, 2100 during operation within the cover 3100. The
sealed housing 1100, 2100 can function as the primary interface for
the user performing the injection. In addition to the housing 1100,
2100 being possibly hermetically sealed, the sealed housing 1100,
2100 may contain additional sealing components MC-215 (see FIG.
26), MC-315 (see FIGS. 31-32) or compounds to completely enclose
the internal chamber of the housing. This sealed chamber may
perform the following functionalities, for example: provide and
maintain internal desired cleanliness criteria, provide a
water-resistant enclosure, and allow for a pressure differential
between the internal and external environments. Some embodiments of
the auto-injector 1 may preserve the desired internal conditions
until the time of injection. The two halves 1100, 2100 that form
the sealed housing, can have a geometry and/or components (e.g.,
1102, 1103, 1104, 1105, 1106, 1107, 1108, 1109, 2101, 2102, 2103,
2104, 2105, 2106, 2108, 2109, 2110, 2112, 2113) that may locate and
secure the internal components.
The following list of items (1-14) describes another example
activation sequence of internal components and mechanisms of the
auto-injector 1 and the individual component interactions,
according to various embodiments.
1.) When the user unlocks the housing 1100, 2100 from the cover
3100, the housing 1100, 2100 automatically moves to an armed
position 3103 (see FIGS. 110-111). The housing 1100, 2100
translates and rotates a certain constrained distance and degree.
The mechanisms that activate the internal activation sequences
inside the sealed housing are triggers or protrusions MC-106,
MC-107 which are molded or formed on a surface of the cover 3100.
Cavities MC-202, MC-211 are molded or formed into the lower half
2100 of the sealed housing 1100, 2100 to allow the sealed housing
and the cover 2100 to rotate and translate relative to one another
without interfering with or damaging the activation or alignment
mechanisms. During the assembly (see position 3105), activation
(see positions 3102, 3103), and injection (see position 3104), the
protrusions or tabs 2107, molded or formed on the sealed housing
1100, 2100 and corresponding channels, slots, detents, etc. 3106,
3108, 3107 (see FIG. 110) on the cover 3100, interface to provide
sufficient clearance and alignment to prevent damage of the
protrusions or triggers MC-106, MC-107 on the cover 3100.
Furthermore, the cover 3100 can have alignment posts or protrusions
MC-105, that interface with corresponding cavities MC-211 in the
sealed housing 1100, 2100 at the time of injection such that they
may aid in the alignment of the sealed housing 1100, 2100 and cover
3100 to orient the triggers MC-106, MC-107 on the cover 3100 with
the corresponding locking mechanisms 5100 (see FIG. 136), 7110 (see
FIG. 116) disposed in the sealed housing 1100, 2100. Additionally,
the cover 3100 and/or sealed housing 1100, 2100 may contain
additional features that aid in maintaining alignment between the
sealed housing 1100, 2100 and the cover 3100 during relative
movement. The automatic expansion may occur due to a spring 3101
(see FIGS. 108-111) disposed or formed therein, to bias the housing
1100, 2100 away from the cover 3100 during activation, to
facilitate use. In certain embodiments the housing 1100, 2100 can
be returned to the locked position 3102 and maintain the internal
sealed nature of the sealed housing. To return to the locked
position 3103, 3104, the user compresses the housing 1100, 2100
into the cover 3100 and rotates the housing 1100, 2100 in the
opposite direction.
2.) In certain embodiments the internal injection needle 4102 is
not aligned with the needle aperture MC-112 formed in the bottom
side of the cover 3100. Therefore, if the injection needle 4102
were to inadvertently misfire, the sharp distal end of the needle
NES-701 would not penetrate through the bottom side of the cover
MC-121. The user may verify the positioning of the housing 1100,
2100 relative to the cover 3100 by means of indicia and labeling
present on the auto-injector 1.
3.) Once the auto-injector 1 is in the unlocked position MC-118 and
has transitioned to the activated position 3103, 3104, the housing
1100, 2100 can rotate freely without interference with the triggers
MC-106, MC-107. Preceding the manual compression of the
auto-injector 1 to facilitate an injection, the housing 1100, 2100
can be reset or returned to the locked position 3102, if accidental
movement to the activated position 3103 has taken place.
4.) When the housing 1100, 2100 is compressed into the cover 3100,
transitioning from the armed position 3104 to the injection
position MC-120, the triggers or protrusions MC-106, MC-107 on the
cover 3100 pierce the designated locations MC-203 on the housing
2100, making contact with the corresponding locks 5100, 7110, and
starting the injection sequence. To allow the triggers MC-106,
MC-107 to penetrate through the bottom side of the lower housing
half 2100 without causing any loose breakage or compromising the
structure of the triggers MC-106, MC-107. Therefore, the areas
MC-203 where the triggers MC-106, MC-107 penetrate may contain
perforations or other aids MC-219 (e.g., different material,
etc.).
5.) When the user compresses the auto-injector 1 to perform the
injection, the first trigger MC-107 pierces the lower housing half
2100 and initiates the uncoiling of the curved injection needle
4102. The uncoiling is initiated by the first trigger MC-107
disengaging the locking mechanism 5100. The first trigger MC-107
pierces the housing and contacts the uncoiling locking mechanism
5100. The uncoiling locking mechanism 5100 is disengaged by being
retracted from the needle barrel 4100 (see FIGS. 125-130) where it
sits during the stored, active, and armed positions 3102, 3103,
3104. The housing 1100, 2100 may have sufficient internal geometry
(see elements MC-306, MC-307 (see FIG. 31)) to assist in the
disengagement of the locking mechanisms 5100, 7110 during the time
of injection. Prior to engagement with the first trigger MC-307,
the uncoiling of the injection needle 4102 may be prevented by the
uncoiling locking mechanism 5100, inhibiting the needle barrel 4100
from rotating. Therefore, the corresponding torsion spring 8100
remains wound and under load. In this embodiment, a portion of the
injection needle 4102 has a helical shape prior to injection and a
straightened out shape at the time of injection. The helical shape
of the injection needle 4102 allows the auto-injector 1 to maintain
a low profile and high aspect ratio. Additionally, the needle 4102
can be of such material that it will not be compromised during
manufacturing or uncoiling during injection.
6.) Once the locking mechanism 5100 is disengaged from the needle
barrel 4100, the torsion spring 8100 is free to rotate the needle
barrel 4100 a set angle. The injection needle 4102 can be fixed to
a retainer 4103 (see FIG. 122) that mates with a corresponding
recess 4112 (see FIGS. 125-126) formed in the needle barrel 4100.
When the needle barrel 4100 rotates, a portion of the helical
injection needle 4102 is uncoiled. In this embodiment, a portion of
the needle 4102 that was curved before injection, can be
straightened and embedded in tissue during the injection. A pair of
opposing ribs 2102 (see FIG. 108), 1104 (see FIGS. 114-115) molded
in the upper half 1100 and the lower half 2100 of the housing keep
the needle barrel 4100 in place and properly aligned during
rotation while both uncoiling and recoiling. In addition, the ribs
or housing 4113 (see FIGS. 125-126), 1104, 2102 that aligns and
guides the needle barrel 4100 may be formed or have such geometry
(see elements 1103 (see FIGS. 114-115), 2103 (see FIG. 112)) that
guides and allows the injection needle 4102 to disengage from the
needle barrel 4100.
7.) The distal end NES-701 of the helical injection needle 4102
passes through an aperture 2111 (see FIGS. 112-113) of similar size
to the injection needle 4102 formed in the lower housing half 2100,
so that the injection needle 4102 is straightened during uncoiling
by the aperture 2111. Controlling the needle barrel's 4100 rotation
by an interference element 4107 (see FIGS. 125-127) ensures the
barrel 4100 is rotated the desired predetermined number of degrees,
ensuring that the distal end NES-701 of the needle 4102 is stopped
at the desired injection depth.
8.) In addition, when the distal end NES-701 of the needle 4102
exits the lower housing half 2100, it may pass through and pierce a
seal covering the aperture 2111. The seal acts as the barrier
between the internals of the housing 1100, 2100 and the outside
environment. This seal may by an adhesively adhered thin TPE
membrane (e.g., Santoprene.RTM. material) that keeps the housing
1100, 2100 hermetically sealed. In addition, this type of seal
allows the distal end NES-701 of the needle 4102 to pass through,
without removing any material, avoiding a corking effect and
partial or complete blocking of the internal lumen or bore of the
needle 4102 during injection. The seal may also ensure that the
sterile internal environment of the housing is maintained.
9.) Once the needle barrel 4100 uncoiling rotation is complete, the
torsion spring 8100 can disengage from the needle barrel 4100. The
torsion spring 8100 can disengage from the needle barrel 4100
because an uncoiling spring tensioner 4104 (see FIG. 128) which is
in contact with both the needle barrel 4100 and the torsion spring
8100 includes a torsion spring contact point 4106 (see FIG. 128)
and collared surface 4105 (see FIGS. 129-130) that has a
noncircular shape. In one embodiment, the torsion spring contact
surface 4114 (see FIGS. 137-138) causes an axial deflection of the
torsion spring 8100, due to the non-circular collar 4105, allowing
the proximal end 8103 (see FIG. 140) of the torsion spring 8100 to
raise up and out of contact point 4106 on the barrel 4100 and
disengage from the needle barrel 4100. Disengagement can occur, so
that the recoil torsion spring 8101 that performs the recoiling of
the injection needle 4102 onto the barrel 4100 does not have to
rewind the uncoiling torsion spring 8100.
10.) After the needle barrel locking mechanism 5100 has been
disengaged by the first trigger MC-107, further compression of the
housing 1100, 2100 into the cover 3100 allows the second trigger
MC-106 to initiate dispensing of the medicament. A plunger 7102
associated with a reservoir or vial 7100 containing the medicament
is propelled or driven forward by a compression spring 7106, which
in turn dispenses the medicament. The compression spring 7106 is
actuated when the second trigger MC-106 released a retainer 7101
that bounds and retains the spring 7106 in a stored position. The
compression spring 7106 drives the retainer 7101 and in turn the
plunger 7102 into the vial 7100, to force the medicament out of the
vial 7100, through the dispensing port 7104.
11.) The proximal end NES-703 of the injection needle 4102 is
fluidically connected to the dispensing port 7104 by a length of
flexible hose or tubing NES-900. The timing of the uncoiling NES
and medicament administration MDS is such that the injection NES
and medicament MDS delivery occur within a short designated time
window (e.g., a few seconds after compression).
12.) Once the auto-injector 1 has been compressed against the
injection location and the injection has commenced, the individual
holds the auto-injector 1 against the injection location for a
designated time duration. Upon release of the pressure on the
auto-injector 1, after the designated time duration, recoiling of
the injection needle 4102 commences. Due to the biasing member
3101, the housing 1100, 2100 automatically expands and upon
expansion releases a third locking 9100 (see FIGS. 133-134)
mechanism which in turn activates the recoiling torsion spring 8101
(see FIG. 129).
13.) While the auto-injector 1 is in the compressed configuration,
the recoil torsion spring 8101 can be maintained in a wound state
by another tensioner 9101 (see FIGS. 131-132) and retainer 9100.
This recoil spring retainer 9100 may maintain the tensioned state
of the recoil torsion spring 8101 during compression of the
auto-injector 1 and injection of the dose. Note that the recoil
spring 8101 may be disengaged from the needle barrel 4100 during
uncoiling of the injection needle 4102. Following the expansion,
after injection, the recoil spring 8101 can engage interference
element 4107 of the needle barrel 4100 such that the injection
needle 4102 is recoiled. This engagement 4107 of the recoiling
spring 8101 on the needle barrel 4100 is facilitated by the axial
movement of the needle barrel 4100 during the uncoiling process. To
prevent the recoil torsion spring 8101 from unwinding (and
recoiling the injection needle 4102 prematurely) once the uncoiling
spring 8100 is disengaged from the needle barrel 4100, the trigger
MC-106 actuates the recoil spring retainer 9100, such that full
auto-injector 1 compression acts as a temporary spring retainer,
until the expansion of the auto-injector 1.
14.) Once the auto-injector 1 is permitted to expand after the
injection has been completed, the trigger MC-106 disengages,
releasing the tensioner 9101 and allowing the recoil torsion spring
8101 to recoil the injection needle 4102 into the housing 1100,
2100. Subsequently an interlock SS-100 prevents the injection
needle 4102 from being able to be deployed again.
The table below provides names and brief descriptions of the
references numerals appearing in the figures:
TABLE-US-00001 REFERENCE NUMERAL NAME DESCRIPTION MDS-100 RETAINER
LOCKING COMPLETE PART MECHANISM MDS-101 RETAINER LOCKING TRIGGER
CONTACT SURFACE MECHANISM MDS-102 RETAINER LOCKING LOCK
DISENGAGMENT MECHANISM SURFACE FOR TH MDS-103 RETAINER LOCKING
RETAINER CONTACT SURFACE MECHANISM MDS-104 RETAINER LOCKING
RETAINER SHEATH CONTACT MECHANISM SURFACE MDS-200 RETAINER KEEPER
COMPLETE PART MDS-201 RETAINER KEEPER RETAINER STROKE HARD STOP
MDS-202 RETAINER KEEPER RETAINER ALIGNMENT RAILS MDS-203 RETAINER
KEEPER RESERVOIR ASSEMBLY TABS MDS-204 RETAINER KEEPER RETAINER
LOCK CONTACT SURFACE MDS-300 RETAINER LEFT HALF COMPLETE PART
MDS-301 RETAINER LEFT HALF ASSEMBLY ALIGNMENT POST/HOLE MDS-302
RETAINER LEFT HALF DISPENSING NEEDLE CHANNEL MDS-303 RETAINER LEFT
HALF FLEXIBLE TUBING CHANNEL MDS-304 RETAINER LEFT HALF MOLDED
FLEXIBLE TUBING CLAMPS MDS-305 RETAINER LEFT HALF U-SONIC WELD
ENERGY DIRECTORS MDS-306 RETAINER LEFT HALF RETAINER LOCK CONTACT
SURFACE MDS-307 RETAINER LEFT HALF DISPENSING NEEDLE BARRIER LIP
MDS-308 RETAINER LEFT HALF DISPENSING SPRING SHOULDER MDS-309
RETAINER LEFT HALF RETAINER KEEPER STROKE STOP CONTACT SURFACE
MDS-310 RETAINER LEFT HALF RETAINER TIP FOR PUSHING THE PLUNGER
MDS-400 RETAINER RIGHT HALF COMPLETE PART MDS-401 RETAINER RIGHT
HALF ASSEMBLY ALIGNMENT POST/HOLE MDS-402 RETAINER RIGHT HALF
DISPENSNIG NEEDLE CHANNEL MDS-403 RETAINER RIGHT HALF FLEXIBLE
TUBING CHANNEL MDS-404 RETAINER RIGHT HALF MOLDED FLEXIBLE TUBING
CLAMPS MDS-405 RETAINER RIGHT HALF U-SONIC ENERGY DIRECTOR WELLS
MDS-406 RETAINER RIGHT HALF RETAINER LOCK CONTACT SURFACE MDS-407
RETAINER RIGHT HALF DISPENSING NEEDLE BARRIER LIP MDS-408 RETAINER
RIGHT HALF DISPENSING SPRING SHOULDER MDS-409 RETAINER RIGHT HALF
RETAINER KEEPER STROKE STOP CONTACT SURFACE MDS-410 RETAINER RIGHT
HALF RETAINER TIP FOR PUSHING THE PLUNGER MDS-500 DISPENSING NEEDLE
COMPLETE PART (CLEANLIESS) BARRIER MDS-501 DISPENSING NEEDLE
PLUNGER FACING SURFACE (CLEANLIESS) BARRIER MDS-502 DISPENSING
NEEDLE SEALING EDGE FOR RETAINER (CLEANLIESS) BARRIER MDS-600
DISPENSING NEEDLE COMPLETE PART MDS-601 DISPENSING NEEDLE LANCET
TIP MDS-602 DISPENSING NEEDLE GRIT BLASTED SURFACE MDS-603
DISPENSING NEEDLE HEEL DULLED AREA (TO PREVENT COREING) MDS-604
DISPENSING NEEDLE PROXIMAL END OF NEEDLE MDS-700 DISPENSING SPRING
COMPLETE PART MDS-701 DISPENSING SPRING RETAINER KEEPER CONTACT
SURFACE MDS-702 DISPENSING SPRING RETAINER SHOULDER CONTACT SURFACE
MDS-800 MEDICAMENT RESERVOIR COMPLETE PART MDS-900 PLUNGER COMPLETE
PART MDS-901 PLUNGER TRIM EDGE (SEALING SURFACE) MDS-902 PLUNGER
DISPENSING NEEDLE BARRIER CONTACT SURFACE NES-100 NEEDLE SHEATH
COMPLETE PART NES-101 NEEDLE SHEATH SNAP FIT EDGE FOR SAFETY
MECHANISM NES-102 NEEDLE SHEATH MOLD PIN SUPPORT WINDOWS NES-103
NEEDLE SHEATH INJECTION NEEDLE GUIDE CUT OUT ON SNAP FIT EDGE
NES-104 NEEDLE SHEATH TOP CURVED CUT OUT FOR FITTING UP TO THE
NEEDLE BARREL NES-200 NEEDLE BARREL COMPLETE PART NES-201 NEEDLE
BARREL NEEDLE BARREL LOCK CUT OUT NES-202 NEEDLE BARREL TORSION
SPRING SLOT CUT NES-203 NEEDLE BARREL FLEXIBLE TUBING CHANNEL CUT
OUT (TO ALLOW FOR TUBING DEFLECTION DURING ROTATION) NES-204 NEEDLE
BARREL FLEXIBLE TUBING CONTACT SURFACE WHILE BEING ULTRASONICALLY
WELDED NES-205 NEEDLE BARREL MOLDED TUBING CLAMPS NES-206 NEEDLE
BARREL INJECTION NEEDLE CHANNEL CUT OUT WITH TEXTURED SURFACE
NES-207 NEEDLE BARREL NEEDLE BARREL CAP SHAFT RECEPTICAL NES-208
NEEDLE BARREL ROTATIONAL ALIGNMENT RIDGE FOR BARREL GUIDE CONTACT
NES-209 NEEDLE BARREL INJECTION NEEDLE CHANNEL (COMPLETED CHANNEL
FORMED AFTER WELDING) NES-210 NEEDLE BARREL ULTRASONIC WELD STEP ON
NEEDLE BARREL FACE NES-300 NEEDLE BARREL CAP COMPLETE PART NES-301
NEEDLE BARREL CAP HARD STOP CUT OUT NES-302 NEEDLE BARREL CAP
TORSION SPRING WINDING CUT OUT IN FACE OF NEEDLE BARREL CAP NES-303
NEEDLE BARREL CAP FLEXIBLE TUBING CHANNEL CUT OUT (TO ALLOW FOR
TUBING DEFLECTION DURING ROTATION) NES-304 NEEDLE BARREL CAP
FLEXIBLE TUBING CONTACT SURFACE WHILE BEING ULTRASONICALLY WELDED
NES-305 NEEDLE BARREL CAP MOLDED TUBING CLAMPS NES-306 NEEDLE
BARREL CAP INJECTION NEEDLE CHANNEL CUT OUT WITH TEXTURED SURFACE
NES-307 NEEDLE BARREL CAP ULTRASONIC WELD ENERGY DIRECTOR NES-308
NEEDLE BARREL CAP NEEDLE BARREL CAP SHAFT NES-309 NEEDLE BARREL CAP
INJECTION NEEDLE CHANNEL (COMPLETED CHANNEL FORMED AFTER WELDING)
NES-400 NEEDLE BARREL GUIDE COMPLETE PART NES-401 NEEDLE BARREL
GUIDE NEEDLE BARREL LOCK CHANNEL NES-402 NEEDLE BARREL GUIDE
TORSION SPRING BRACE LEG CUT OUT NES-403 NEEDLE BARREL GUIDE NEEDLE
BARREL TAIL ROTATION STABILIZING HOLE NES-404 NEEDLE BARREL GUIDE
NEEDLE BARREL SHOULDER, FOR SETTING DEPTH OF NEEDLE BARREL IN THE
GUIDE NES-500 NEEDEL BARREL LOCK COMPLETE PART NES-501 NEEDEL
BARREL LOCK TRIGGER CONTACT SURFACE NES-502 NEEDEL BARREL LOCK LOCK
DISENGAGEMENT SURFACE FOR THE TOP HALF NES-503 NEEDEL BARREL LOCK
LOCKING DEPTH SHOULDER FOR THE NEEDLE BARREL GUIDE NES-504 NEEDEL
BARREL LOCK NEEDLE BARREL CONTACT SURFACE NES-600 NEEDLE SHEATH
COMPLETE PART (CLEANLIENESS) BARRIER NES-601 NEEDLE SHEATH MOLDED
RIBBING FOR PRESS (CLEANLIENESS) BARRIER FITTING IN NEEDLE SHEATH
NES-602 NEEDLE SHEATH TOP CURVED CUT OUT FOR (CLEANLIENESS) BARRIER
FITTING UP TO THE NEEDLE BARREL NES-700 INJECTION NEEDLE COMPLETE
PART NES-701 INJECTION NEEDLE DISTAL END/LANCET TIP NES-702
INJECTION NEEDLE GRIT BLASTED SURFACE NES-703 INJECTION NEEDLE
PROXIMAL END NES-800 TORSION SPRING COMPLETE PART NES-801 TORSION
SPRING ROTATIONAL LEG MAKING CONTACT WITH THE NEEDLE BARREL NES-802
TORSION SPRING BRACING LEG (SUPPORTED ON THE NEEDLE BARREL GUIDE)
NES-900 FLEXIBLE TUBING COMPLETE PART SS-100 AUTO-INJECTOR COMPLETE
PART INTERLOCK SS-101 AUTO-INJECTOR LOCKOUT ENGAGMENT ARM INTERLOCK
SS-102 AUTO-INJECTOR KICK BACK FOOT INTERLOCK SS-103 AUTO-INJECTOR
SLANTED FOOT FOR LOCKOUT INTERLOCK SS-200 SAFETY MECHANISM COMPLETE
PART SS-201 SAFETY MECHANISM TAPERED LEAD IN EDGE FOR NEEDLE SHEATH
SS-202 SAFETY MECHANISM ALIGNMENT PROTRUSIONS FOR ASSEMBLY (FIT IN
GRABBER UNDECUTS) SS-203 SAFETY MECHANISM NEEDLE SHEATH HOLE SS-204
SAFETY MECHANISM LOCKING POST SS-300 EXPANSION SPRING COMPLETE PART
SS-301 EXPANSION SPRING CONTACT SURFACE FOR BOTTOM HALF SS-302
EXPANSION SPRING CONTACT SURFACE FOR COVER MC-100 COVER COMPLETE
PART MC-101 COVER EXPANSION SLOTS FOR ASSEMBLY MC-102 COVER
ASSEMBLY ALIGNMENT CHANNELS FOR EXPANSION TABS ON THE BOTTOM HALF
MC-103 COVER ROTATIONAL CHANNEL FOR THE EXPANSION TABS ON THE
BOTTOM HALF MC-104 COVER EJECTOR PIN LOCATIONS MC-105 COVER
ALIGNMENT POSTS FOR THE BOTTOM HALF DURING INJECTION MC-106 COVER
RETAINER TRIGGER MC-107 COVER NEEDLE BARREL LOCK TRIGGER MC-108
COVER EXPANSION SPRING RECESS CUT MC-109 COVER PUCK STOPPER GRABBER
CONTACT SURFACE FOR THE STOPPER MC-110 COVER INJECTION NEEDLE GUIDE
MC-111 COVER NEEDLE SHEATH HOLE MC-112 COVER INJECTION NEEDLE HOLE
MC-113 COVER INJECTION NEEDLE GUIDE TAPERED UNDERCUT TO PREVENT
PLASTIC SCORING MC-114 COVER GRABBER UNDERCUT HOLE FOR THE SAFETY
COVER PROTRUSIONS MC-115 COVER WALL CUT AWAY FOR STOPPER CLEARANCE
MC-116 COVER PERIMETER WALL CUT TO PREVENT DEFORMATION DURING
MOLDING MC-117 COVER STORED/LOCKED POSITION MC-118 COVER UNLOCKED
POSITION MC-119 COVER ARMED POSITION MC-120 COVER INJECTION
POSITION MC-121 COVER INJECTION SURFACE MC-200 BOTTOM HALF COMPLETE
PART MC-201 BOTTOM HALF HOUSINGS FOR PUCK STOPPERS MC-202 BOTTOM
HALF HOUSINGS FOR TRIGGERS AND ALIGNMENT POSTS (DURING STORED
STATE) MC-203 BOTTOM HALF TRIGGER HOLES MC-204 BOTTOM HALF NEEDLE
SHEATH HOLE MC-205 BOTTOM HALF RETAINER KEEPER RECESS CUT MC-206
BOTTOM HALF RESERVOIRCUT OUT/ RESERVOIRCRADDLE MC-207 BOTTOM HALF
NEEDLE BARREL CRADDLE MC-208 BOTTOM HALF RESERVOIRBRACING WALL
MC-209 BOTTOM HALF ASSEMBLY FINS FOR TOP HALF MC-210 BOTTOM HALF
ROTATION/EXPANSION TABS MC-211 BOTTOM HALF ALIGNMENT POST HOUSINGS
FOR INJECTION MC-212 BOTTOM HALF PUCK STOPPER LEDGE FOR DEVICE LOCK
OUT MC-213 BOTTOM HALF EXPANSION SPRING RECESS
CUT OUT MC-214 BOTTOM HALF INJECTION NEEDLE GUIDE CUT OUT MC-215
BOTTOM HALF PUCK SEALING SURFACE WITH TEXTURED PROFILE MC-216
BOTTOM HALF NEEDLE BARREL GUIDE PLATFORM MC-217 BOTTOM HALF KEYED
SLOT FOR SAFETY PLATE MC-218 BOTTOM HALF HARD STOP FOR NEEDLE
BARREL ROTATION MC-219 BOTTOM HALF TIRGGER BRACING MC-300 TOP HALF
COMPLETE PART MC-301 TOP HALF FINGER PLACEMENT LOCATIONS (FOR
ROTATION) MC-302 TOP HALF RIDGE ON TOP SURFACE FOR NEEDLE BARREL
GUIDE AND ROTATIONAL AID MC-303 TOP HALF ASSEMBLY FIN CUT OUTS FOR
BOTTOM HALF MC-304 TOP HALF RESERVOIRCUT OUT/CRADDLE FOR VIAL
MC-305 TOP HALF CUT OUT FOR THE RETAINER KEEPER MC-306 TOP HALF
RETAINER LOCK DISENGAGEMENT RAMP MC-307 TOP HALF NEEDLE BARREL LOCK
DISENGAGEMENT RAMP MC-308 TOP HALF EJECTOR PIN LOCATION ON NEEDLE
BRACE MC-309 TOP HALF INJECTION NEEDLE BRACE MC-310 TOP HALF
FLEXIBLE TUBING CUT OUT FOR ROTATING AROUND THE NEEDLE BARREL
MC-311 TOP HALF RESERVOIRBRACING WALL MC-312 TOP HALF NEEDLE BARREL
LEDGE CUT (KEEPS THE NEEDLE BARREL INSIDE THE GUIDE DURING ROTATION
BY PREVENTING AXIAL DISPLACEMENT) MC-313 TOP HALF NEEDLE BARREL
GUIDE CUT OUT MC-314 TOP HALF PUCK STOPPER HOUSINGS MC-315 TOP HALF
PUCK SEALING SURFACE/RIM MC-316 TOP HALF NEEDLE BARREL TAIL CUT OUT
1 AUTOINJECTOR ASSEMBLY FULL ASSEMBLY INCLUDING THE COVER 1100 TOP
HALF TOP HALF 1101 TOP HALF FINGER TAB 1102 TOP HALF ASSEMBLY
ALIGNMENT HOLES 1103 TOP HALF MALE THREAD FOR HELIX 1104 TOP HALF
MIDDLE HOUSING 1105 TOP HALF RESERVOIRRECESS CUT TOP HALF 1106 TOP
HALF RECOILING SPRING CUTOUT 1107 TOP HALF RESERVOIRCRADDLE HOUSING
SIDE 1108 TOP HALF RESERVOIRCRADDLE OUTSIDE EDGE 1109 TOP HALF
RETAINER GUIDE HOUSING 2100 BOTTOM HALF BOTTOM HALF 2101 BOTTOM
HALF ASSEMBLY ALIGNMENT PYRAMIDS 2102 BOTTOM HALF MIDDLE HOUSING
2103 BOTTOM HALF MALE THREAD FOR HELIX ALIGNMENT 2104 BOTTOM HALF
RESERVOIRRECESS CUT BOTTOM HALF 2105 BOTTOM HALF RESERVOIRCRADDLE
HOUSING SIDE 2106 BOTTOM HALF RESERVOIRCRADDLE OUTSIDE EDGE 2107
BOTTOM HALF EXPANSION TABS 2108 BOTTOM HALF RESERVOIRREAR BRACE
BOTTOM HALF 2109 BOTTOM HALF UNCOILING SPRING BRACE 2110 BOTTOM
HALF HELIX LOCK GUIDE CHANNEL 2111 BOTTOM HALF INJECTION NEEDLE
HOLE IN BOTTOM HALF 2112 BOTTOM HALF RETAINER GUIDE HOUSING 2113
BOTTOM HALF RECOIL LOCK ALIGNMENT SLOTS 3100 COVER COVER WITH
MOLDED SPRINGS 3101 COVER MOLDED SPRINGS 3102 COVER
STORED/COLLAPSED CONFIGURATION POSITION 3103 COVER ACTIVATED
CONFIGURATION POSTION 3104 COVER ARMED CONFIGURATION POSITION 3105
COVER ASSEMBLY SHOULDER IN COVER FOR REACHING STORED POSITION 3106
COVER EXPANSION CHANNEL IN COVER 3107 COVER STORED/COLLAPSED
POSITION LOCK 3108 COVER ACTIVE TO ARMED LOCK 4100 NEEDLE BARREL
HELIX 4101 NEEDLE BARREL NEEDLE BARREL WITH SLANTED CHANNEL 4102
NEEDLE BARREL COILED NEEDLE 4103 NEEDLE BARREL COILED NEEDLE COLLAR
4104 NEEDLE BARREL UNCOILING TENSIONER 4105 NEEDLE BARREL UNCOILING
TENSIONER LOBED HEAD 4106 NEEDLE BARREL UNCOILING TORSIONAL SPRING
SLOT IN HELIX 4107 NEEDLE BARREL RECOILING SPRING SLOT IN HELIX
4108 NEEDLE BARREL NEEDLE BARREL WITH SLANT CUT TORSIONAL SPRING
SLOT 4109 NEEDLE BARREL UNCOILING TENSIONER SQUARE HOLE FOR WINDING
4110 NEEDLE BARREL SLANTED CHANNEL NEEDLE BARREL THRUST BEARING
4111 NEEDLE BARREL SLANTED CHANNEL INJECTION NEEDLE GUIDE CHANNEL
4112 NEEDLE BARREL NEEDLE COLLAR SLOT IN HELIX 4113 NEEDLE BARREL
NEEDLE GUIDE GROOVE IN HELIX 4114 NEEDLE BARREL UNCOILING TENSIONER
TORSIONAL SPRING SLOT 5100 NEEDLE BARREL LOCK HELIX LOCK 5101
NEEDLE BARREL LOCK SLANTED CUT FOR TRIGGER 5102 NEEDLE BARREL LOCK
SLANTED CUT HELIX SIDE 7100 MEDICAMENT RESERVOIR & VIAL
ASSEMBLY 7101 MEDICAMENT RESERVOIR & RETAINER ASSEMBLY 7102
MEDICAMENT RESERVOIR & PLUNGER ASSEMBLY 7103 MEDICAMENT
RESERVOIR & SHEATH ASSEMBLY 7104 MEDICAMENT RESERVOIR &
RESERVOIR MOLDED IN 90 ASSEMBLY DEGREE ELBOW TIP 7105 MEDICAMENT
RESERVOIR & PLUNGER MOLDED RECEPTICLE ASSEMBLY FOR RETAINER
7106 MEDICAMENT RESERVOIR & DISPENSING SPRING ASSEMBLY 7107
MEDICAMENT RESERVOIR & RETAINER TIP FOR PLUNGER ASSEMBLY 7108
MEDICAMENT RESERVOIR & RETAINER SHOULDER FOR ASSEMBLY GRABBING
SHEATH/DISPENSING SPRING 7109 MEDICAMENT RESERVOIR & RETAINER
SHOULDER FOR ASSEMBLY PLUNGER 7110 MEDICAMENT RESERVOIR &
RETAINER RELEASE TABS ASSEMBLY 8100 TORSION SPRING UNCOILING
TORSIONAL SPRING 8101 TORSION SPRING RECOILING TORSIONAL SPRING
8102 TORSION SPRING UNCOILING TORSIONAL SPRING ANTI-ROTATIONAL TAIL
8103 TORSION SPRING UNCOILING TORSIONAL SPRING HELIX END 8104
TORSION SPRING RECOILING TORSIONAL SPRING ANTI-ROTATIONAL TAIL 8105
TORSION SPRING RECOILING TORSIONAL SPRING HELIX END 9100 RECOIL
SYSTEM RECOIL LOCK 9101 RECOIL SYSTEM RECOILING SPRING TENSIONER
9102 RECOIL SYSTEM RECOIL LOCK LIVING HINGE 9103 RECOIL SYSTEM
RECOIL LOCK ALIGNMENT SLOTS 9104 RECOIL SYSTEM RECOILING TENSIONER
SLOT FOR WINDING 9105 RECOIL SYSTEM RECOILING TENSIONER SLOT FOR
LOCKING 9106 RECOIL SYSTEM RECOILING TENSIONER TORSION SPRING SLOT
9107 RECOIL SYSTEM RECOIL LOCK NEEDLE BARREL PIECE
Each numerical value presented herein is contemplated to represent
an exemplary minimum value or a maximum value in a range for a
corresponding parameter. Accordingly, when added to the claims, the
exemplary values provide express support for claiming the range,
which may lie above or below the numerical value, in accordance
with the teachings herein. Every value between the minimum value
and the maximum value within each numerical range presented herein
(including in the chart shown in FIG. 141), is contemplated and
expressly supported herein, subject to the number of significant
digits expressed in each particular range.
The terms and expressions employed herein are used as terms and
expressions of description and not of limitation and there is no
intention, in the use of such terms and expressions, of excluding
any equivalents of the features shown and described or portions
thereof. In addition, having described certain embodiments of the
invention, it will be apparent to those of ordinary skill in the
art that other embodiments incorporating the concepts disclosed
herein may be used without departing from the spirit and scope of
the invention. The structural features and functions of some
embodiments may be arranged in various combinations and
permutations, and all are considered to be within the scope of the
disclosed invention. Unless otherwise necessitated, recited steps
in the various methods may be performed in any order and certain
steps may be performed substantially simultaneously. Accordingly,
the described embodiments are to be considered in all respects as
only illustrative and not restrictive. Furthermore, the
configurations described herein are intended as illustrative and in
no way limiting. Similarly, although physical explanations have
been provided for explanatory purposes, there is no intent to be
bound by any particular theory or mechanism, or to limit the claims
in accordance therewith.
* * * * *
References